Manages levodopa/carbidopa. ANDA 75352, held by Novitium Pharma. Selegiline Hydrochloride.
As of Nov 15, 2026, ANDA 75352 (Selegiline Hydrochloride), held by Novitium Pharma, was first approved by FDA on Nov 30, 1998, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE Selegiline hydrochloride capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Selegiline Hydrochloride5MG · capsule;oral | Selegiline Hydrochloride | Rx |
| Apr 11, 2006 | Supplement 3Labeling | Approved | None posted |
| Nov 30, 1998 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
